Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)
2018年1月7日 更新者:Cubist Pharmaceuticals LLC
An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
研究概览
详细说明
This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin.
Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Written informed consent prior to any study-related procedure not part of normal medical care;
- Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
- Male or female >18 years of age;
- If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for >28 days after study completion;
- If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration;
- Functioning dialysis access (e.g. graft or fistula) for subjects undergoing HD and functioning dialysis access (e.g. peritoneal catheter) for subjects undergoing CAPD;
- ESRD on stable HD regimen of thrice weekly sessions with high-flux membranes or stable CAPD regimen.
Exclusion Criteria:
- If female, pregnant or lactating;
- Received an investigational drug (including experimental biologic agents) within 30 days of study entry;
- Evidence of active ongoing infection;
- Unable to discontinue use of HMG-CoA reductase inhibitor therapy for duration of study;
- Has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug;
- Known to be allergic or intolerant to daptomycin;
- Body Mass Index (BMI) < 18.5 or > 40 kg/m2 [BMI = weight (kg)/height (m2)];
- WBC >12, 000 cells/mm3 or <2500 cells/ mm3;
- Baseline creatinine phosphokinase (CPK) values >3X ULN (upper limit of normal);
- Alanine aminotransferase (ALT) >5X ULN;
- Aspartate aminotransferase (AST) >5X ULN;
- Known HIV-infected subjects with CD4 count ≤200 cells/mm3;
- Hemoglobin < 9 gm/dL;
- Active illicit drug and/or alcohol abuse;
- Myocardial infarction within last 6 months;
- Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days;
- Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy);
- Subjects with a history of neurological disease (e.g., Guillain Barré, multiple sclerosis), except stroke >6 months prior to study entry;
- Intramuscular injection within 7 days of study drug administration;
- Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days);
- Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
- Neutropenic subjects with absolute neutrophil count ≤500 cells/mm3 History of rhabdomyolysis.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Hemodialysis (HD) Participants
Participants will receive daptomycin 6 mg/kg by intravenous infusion (i.v.) at 48-hours intervals (with dialysis) for a total of 3 doses.
|
6mg/kg, i.v.
infusion over 30 minutes; every 48 hours for a total of 3 doses
其他名称:
|
实验性的:Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants
Participants will receive daptomycin 6 mg/kg, i.v., at 48-hours intervals for a total of 3 doses.
|
6mg/kg, i.v.
infusion over 30 minutes; every 48 hours for a total of 3 doses
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Pharmacokinetics
大体时间:Study Day 1, 3, 5 and 7 or 8
|
Study Day 1, 3, 5 and 7 or 8
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Safety and Tolerability
大体时间:Study Days 1 through 16 or 17
|
Study Days 1 through 16 or 17
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年8月12日
初级完成 (实际的)
2008年5月12日
研究完成 (实际的)
2008年5月12日
研究注册日期
首次提交
2007年6月22日
首先提交符合 QC 标准的
2007年6月22日
首次发布 (估计)
2007年6月25日
研究记录更新
最后更新发布 (实际的)
2018年1月9日
上次提交的符合 QC 标准的更新
2018年1月7日
最后验证
2018年1月1日
更多信息
与本研究相关的术语
其他研究编号
- 3009-021
- DAP-REN-07-01 (其他标识符:Cubist Study Number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.